Effect of Fermented Protaetia Brevitarsis Seulensis Powder on Alcohol-induced Liver Disease

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorPusan National University Yangsan Hospital

About this trial

The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Fermented Protaetia brevitarsis seulensis powder on Alcohol-induced Liver Disease in adults for 8 weeks.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Gamma-glutamyl transferase ranging from upper limit of reference to four times of upper limit

Disqualifiers

Abnormal liver or renal function (i.e., serum aminotransferase activity > 3 times of upper limit of reference range and serum creatinine concentrations > 1.2 mg/dL)

Diabetes (diagnosed clinically or fasting glucose level > 126 mg/dL)

History of viral hepatitis or cancer

Uncontrolled hypertension

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fermented Protaetia brevitarsis seulensis powder group

    Dietary supplement

    This group takes Fermented Protaetia brevitarsis seulensis powder for 8 weeks

  • Placebo group

    Dietary supplement

    This group takes placebo for 8 weeks

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Fermented Protaetia brevitarsis seulensis powder groupExperimental treatment 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Concentration of Gamma-Glutamyl Transpeptidase

Gamma-Glutamyl Transpeptidase

Time frame
8 weeks

Secondary outcomes

1

Concentration of Aspartate aminotransferase

Aspartate aminotransferase

Time frame
8 weeks
2

Concentration of Alanine aminotransferase

Alanine aminotransferase

Time frame
8 weeks
3

Fatigue Severity Scale

Fatigue Severity Scale, minimum\~maximum values (1\~7), higher scores mean a worse outcome.

Time frame
8 weeks

Other outcomes

Sponsors and contacts

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